MYNTSMILE DIAMYNT- sodium monofluorophosphate paste, dentifrice 
LMKAO LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

MYNTSMILE DIAMYNT

Active Ingredient:

Sodium Monofluorophosphate 0.83% w/w

Purpose:

Anti cavity toothpaste.

Uses:

Aids in the prevention of dental cavities.

Warnings:

As with all fluoride toothpastes, Keep out of reach of children under 6 yrs of age.

If you accidentally swallow more than used for brushing, get medical help or contact a poison control center right away.


Directions

For best results: Brush teeth thoroughly after each meal, at least twice a day, or as directed by a dentist. Instruct children under six about good brushing and rinsing habits to minimize swallowing.

Supervise children as necessary until capable of using without supervision. Under two years of age consult a dentist or a doctor before use.

Inactive ingredients:

Water, Glycerin, Hydrated Silica, Sorbitol, Xanthan Gum, Titanium Dioxide, Flavor, Cocamidopropyl Betaine, Xylitol, Aloe Barbadensis Leaf Juice, Mentha Piperita (Peppermint) Leaf Extract, Salvia Officinalis (Sage) Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extarct, Diamond Powder

Questions: 1-855-MYNT-SMILE

www.myntsmile.com

PATENT PENDING FORMULA

Distributed by:

LMKAO LLC, New York, NY

10006 Made in USA






DIAMYNT TUBE LABEL

DIAMYNT TUBE LABEL






DIAMYNT BOX LABEL

DIAMYNT BOX LABEL

MYNTSMILE  DIAMYNT
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42357-001
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM MONOFLUOROPHOSPHATE0.83 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
SORBITOL (UNII: 506T60A25R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
XYLITOL (UNII: VCQ006KQ1E)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
MENTHA PIPERITA (UNII: 79M2M2UDA9)  
SAGE (UNII: 065C5D077J)  
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
DIAMOND (UNII: 6GRV67N0U2)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42357-001-011 in 1 BOX
1112 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35503/10/2012
Labeler - LMKAO LLC (078346159)

Revised: 3/2012
Document Id: 7a1634c5-6e0f-4ed0-adca-467963541107
Set id: cc5cfe69-e188-43c9-bbaa-c283a06d1ee3
Version: 1
Effective Time: 20120310
 
LMKAO LLC